Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Launched by IPSEN · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Odevixibat Pregnancy and Lactation Surveillance Program, is looking to understand how safe the medication odevixibat is for women who are pregnant or breastfeeding. If you are a woman who has taken at least one dose of odevixibat during your pregnancy (from one day before conception until the baby is born) or while breastfeeding (up to 12 months after the baby is born), you may be eligible to participate in this study. The trial is observational, meaning researchers will gather information from your regular medical visits without requiring any extra tests or procedures.

Participants can expect that their healthcare providers will continue to manage their care as usual, and the study will collect information already documented in medical records. This program aims to ensure that the safety of odevixibat is well understood during this important time in a woman's life, and your participation could help provide valuable insights for other mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).
• • Informed consent or IRB-/EC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)
• Exclusion Criteria:
• • Refusal to provide informed consent, if required